Application 061996
- Type
- ANDA
- Sponsor
- CHARTWELL RX
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | FULVICIN P/G | GRISEOFULVIN, ULTRAMICROCRYSTALLINE | TABLET;ORAL | 125MG | No | No |
| 002 | FULVICIN P/G | GRISEOFULVIN, ULTRAMICROCRYSTALLINE | TABLET;ORAL | 250MG | No | No |
| 003 | FULVICIN P/G 165 | GRISEOFULVIN, ULTRAMICROCRYSTALLINE | TABLET;ORAL | 165MG | No | No |
| 004 | FULVICIN P/G 330 | GRISEOFULVIN, ULTRAMICROCRYSTALLINE | TABLET;ORAL | 330MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 62135-494 | Ultramicrosize Griseofulvin | Griseofulvin | Chartwell RX, LLC. | ANDA | Current |
| 62135-494 | Ultramicrosize Griseofulvin | Griseofulvin | Chartwell RX, LLC. | ANDA | Current |
| 62135-495 | Ultramicrosize Griseofulvin | Griseofulvin | Chartwell RX, LLC. | ANDA | Current |
| 62135-495 | Ultramicrosize Griseofulvin | Griseofulvin | Chartwell RX, LLC. | ANDA | Current |